Efficacy and Safety of Ivermectin in Treatment of Mild to Moderate COVID-19 Infection: a Randomized ,Double Blind,Placebo,Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Viral clearance of SARS- CoV-2 intervention
研究概览
简要总结
The newly emerged corona virus disease 2019 (COVID-19) has spread to all over the world, with recent estimates of more than 236 million cases diagnosed and led to 4.8 million deaths as November 20211 .Therapeutic approaches are needed to improve outcomes in patients with COVID-19 since no antiviral agent has yet been proved to be conclusively beneficial in COVID-19 infection,especially in patients with mild to moderate degree of severity There has been growing interest in the anti-parasitic drug,ivermectin, which previously was studied as an antiviral, anti-inflammatory and anti-cancer actions2 .It was also reported to have an in-vitro activity against SARS-CoV-23 .Its antiviral properties was due to the action on importin 2/1 mediated nuclear transport. Ivermectin prevents the binding of viral proteins to importin 2/1 rendering the viral proteins unable to enter the nucleus and cause infection4.
Several clinical studies have found a beneficial effect of ivermectin in COVID-195-9 However, some study did not find significant difference between the patient group receiving ivermectin and control group10 .Until now, the controlled trials evaluating ivermectin in COVID-19 are lacking. Ivermectin is safe, with reported side effect of less than 1%. Hence it is essential to conduct a clinical trial with ivermectin in patients with COVID-19 .The objective of this study is to establish the efficacy of ivermectin for COVID-19 patients with mild to moderate disease, compare to usual case alone.
详细描述
This study is a randomized, double-blind, placebo controlled trial conducted at Faculty of Medicine, Vajira Hospital, Navamindradhiraj University from September 2021 to the end of November 2021.
The patients were randomized in permuted block of four in a randomized sequence prepared by the unblinded pharmacist in Microsoft excel12 .Allocation assignment was concealed from investigators and the patients. The patients were allocated into two groups : either to group A (Ivermectin arm) or to group B (control arm) as shown in Fig 1. The patients were randomized in a 1:1 ratio .Group A received ivermectin 12 mg per day for 5 days as recommended by previous studes13,14 plus standard care. Group B was to receive standard care alone which included favipiravir or andrographolide, corticosteroids, cetrizine and paracetamol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Group A: Ivermectin Group B: Placebo
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult men and women age 18-80 years
- •non-pregnant or breast-feeding women
- •had mild to moderate symptoms as defined by the World Health Organization (WHO) severity score for COVID-19 Mild disease was defined as cough , runny nose,anosmia, fever, diarrhea without dyspnea or tachypnea.
- •Moderate disease was defined as pneumonia but with oxygen saturation more than 90 percent
排除标准
- •were allergic to ivermectin
- •have the potential for a drug-drug interaction with ivermectin such as tamoxifen or warfarin
- •previously treated with ivermectin in the last 7 days
- •had received any herbal medicine
- •had severe chronic illness (severe congestive heart failure, chronic kidney disease stage 4-5, chronic liver disease, terminal cancer diseases)
- •had concurrent bacterial infection or unwilling to participate in the trial
- •Patients with severe symptoms, likely due to cytokine release syndrome
- •uncontrolled co-morbidities and immunocompromised states
研究组 & 干预措施
Ivermectin
Ivermectin 12 mg per day for 5 plus standard care
干预措施: Ivermectin (Drug)
Ivermectin
Ivermectin 12 mg per day for 5 plus standard care
干预措施: Placebo (Drug)
Placebo
Placebo plus standard care
干预措施: Ivermectin (Drug)
Placebo
Placebo plus standard care
干预措施: Placebo (Drug)
结局指标
主要结局
Viral clearance of SARS- CoV-2 intervention
时间窗: 14 days
Viral load from RT-PCR test
次要结局
- frequency of clinical worsening(28 days)
- Duration of hospitalization(28 days)
- Mechanical ventilation(28 days)
- Mortality rate(28 days)
研究者
Thananda Trakarnvanich
Associate Professor
Bangkok Metropolitan Administration Medical College and Vajira Hospital